Madrigal, FDA approval in hand, outlines plan to sell MASH drug
15 Mar 2024
Accelerated Approval
The first drug for metabolic dysfunction-associated steatohepatitis will cost $47,400 per year, its developer, Madrigal Pharmaceuticals, said Thursday.
Madrigal revealed the price and launch plan for Rezdiffra on a conference call discussing the decision by the Food and Drug Administration to approve the medicine.
Rezdiffra is the first available therapy for MASH, a disease caused by a buildup of fat in the liver that leads to progressive organ damage. Its availability is a milestone in the fight against the condition, which has bedeviled drugmakers for about a decade.
MASH is projected to affect millions of people globally and as a result has been seen by Wall Street analysts as a significant and untapped market opportunity. In its statement Thursday, the FDA noted that about 6 to 8 million people in the U.S. are estimated to have MASH with moderate to severe liver scarring, making them eligible for treatment with Rezdiffra.
Yet the sales outlook for Rezdiffra has long been uncertain. MASH often goes undiagnosed for years and is typically confirmed through a liver biopsy, a painful and expensive procedure. Some of its symptoms can also be addressed through diet and exercise. And more recently, a popular group of weight loss medicines have shown promise treating the condition, with early results that compare favorably with Rezdiffra and other MASH drugs in development.
Notably, Rezdiffra’s prescribing information doesn’t require patients to receive a liver biopsy before treatment, something Wall Street analysts pointed to Thursday as boosting both Madrigal and the broader MASH field. It also didn’t include any “unexpected or onerous monitoring requirement,” wrote Leerink Partners analyst Thomas Smith. “The label appears clean.”
Those factors made for a “near-best case scenario,” according to Smith, and Madrigal’s shares climbed more than 20% following the news.
Still, Madrigal now faces the challenge of identifying patients for treatment and convincing insurers that Rezdiffra is worth the cost. Analysts forecasted a list price of at least $30,000 per year. At $47,400, the cost is “above our expectations,” but still within the threshold of cost-effectiveness set by the Institute for Clinical and Economic Review, a prominent drug pricing watchdog, Smith wrote.
Madrigal was also given an accelerated approval based on Rezdiffra’s ability to affect markers associated with the disease, and some outside experts have described the drug’s effects as modest. An ongoing trial meant to prove whether treatment can improve health outcomes is ongoing, with results expected in 2026 or 2027.
Madrigal executives said the company will initially focus on the 315,000 MASH patients in the U.S.with moderate to advanced fibrosis and are seen by a group of 14,000 physician specialists it’s specifically targeted. The company’s data show that, in clinical testing, Rezdiffra halted or reversed liver scarring in about 80% of patients fitting that description
“This is a high value medicine for a disease that has a significant burden on patients and the healthcare system,” said CEO Bill Sibold, on Thursday’s call. “Now it's about wiring the system over the next 12 months to develop the market the right way.”
To do so, Madrigal has to ensure Rezdiffra is added to electronic medical record systems in doctors’ offices, align physicians on what noninvasive tests could be used to diagnose patients and get the support of insurers.
Based on discussions with insurers, Madrigal doesn’t expect them to mandate liver biopsies to receive treatment, Sibold said. But the company does anticipate that they’ll require prior authorization and to establish testing requirements for diagnosis as part of the reimbursement process. Additionally, filling prescriptions could initially take 60 days, and Madrigal expects physicians to prescribe Rezdiffra only when patients come in for their annual or bi-annual visits.
Taken together, those factors could make for a slow initial launch trajectory, according to executives. But Sibold said coverage will steadily ramp up in 2024, with about 80% of people on commercial insurance covered by the end of the year, and Medicare following in 2025.
“Over the next 12 months, we are taking the important first steps required to build a blockbuster and establish ourselves as the leading [MASH] company,” Sibold said.
Smith, of Leerink, forecasts $76 million in revenue this year and peak sales of about $3.5 billion worldwide by 2030.
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